UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An open label, single institute, single arm trial of efficacy and safety of the anti-RANKL monoclonal antibody (Denosumab) for patients with steroid-induced osteoporosis
Title of the study (Brief title)	OSRANKLE-SIO study
Region	Japan

Condition
Condition	steroid induced osteoporosis
Classification by specialty	Endocrinology and Metabolism Neurology Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the the efficacy and safety of anti-RANKL monoclonal antibody (Denosumab) for steroid induced osteoporosis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Change in bone mineral density of lumber spine In case of spinal bone osteo-sclerosis or spinal bone fracture, femoral neck or distal 2th finger will be substituted Incidence rate of pathological bone fracture Fracture was validated by x-ray and/or MRI scan
Key secondary outcomes	Change in bone metabolism markers NTX(serum , urine), bone-type alkaline phosphatase, Magnesium, Calcium, phosphorus, intact PTH, calcitonin Correlation between bone mineral density and activated vitamin D blood concentration levels Numerical rating score will be measured for pain

Base
Study type	Interventional

Study design
Basic design	Factorial
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Patients will be subcutaneous injected subcutaneously with 60 mg of denosumab every 6 months for 12 months. All subjects will be treated with daily pills containing calcium, naive Vitamin D, with magnesium supplementation. Activated form of vitamin D will be introduced for patients with impaired renal function of serum creatinine value of 2 or more.
Interventions/Control_2	Discontinue the administration of aredoron acid, risedronate, of minodronic acid. All subjects will be received daily pills containing calcium and naive vitamin D, and magnesium supplementation. Activated forms of vitamin D will be introduced for patients with impaired renal function of serum creatinine value of 2 or more.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Plan to use or administration of oral steroid for more than 3 months With written informed consent
Key exclusion criteria	1)Cancer patients with bone metastasis or expected bone metastasis 2)Hypocalcemia 3)Women who wish to be pregnant or are pregnant, or in lactation 4)Hypersensitivity to the denosumab 5)Cancer patients on cancer treatment or anti-hormonal therapy 6)Dental therapy during this trial 7)Long term use of bisphosphonate and have atypical fracture 8)Severe skin infection
Target sample size	130

Research contact person
Name of lead principal investigator	Nobutaka Hattori
Organization	Juntendo University School of Medicine
Division name	Neurology
Address	2-1-1 Hongo bunkyo Tokyo 113-8421Japan
TEL	03-3813-3111
Email	kazumasa@juntendo.ac.jp

Public contact
Name of contact person	Kazumasa Yokoyama
Organization	Juntendo University School of Medicine
Division name	Neurology
Address	2-1-1 Hongo bunkyo Tokyo 113-8421 Japan
TEL	03-3813-3111
Homepage URL
Email	kazumasa@juntendo.ac.jp

Sponsor
Institute	Juntendo University
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	self
Name of secondary funｄer(s)	None

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	順天堂大学附属順天堂医院（東京都)

Other administrative information
Date of disclosure of the study information	2013 Year 08 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 07 Month 26 Day
Anticipated trial start date	2013 Year 08 Month 01 Day
Last follow-up date	2015 Year 07 Month 31 Day
Date of closure to data entry	2015 Year 12 Month 31 Day
Date trial data considered complete	2016 Year 03 Month 31 Day
Date analysis concluded	2016 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 08 Month 12 Day
Last modified on	2018 Year 02 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013241